Otc - Active Ingredient
Octocrylene 4%
Octyl Methoxycinnamate 7.5%,
Octyl Salicylate 4%,
Oxybenzone 5%
Derma Soleil Dry Sports 30 Spf
FDA Label NDC 69711-910
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Soleil for the product Derma Soleil Dry Sports 30 Spf (NDC 69711-910). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Otc - When Using
Helps prevent sunburn
If used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.
Indications & Usage
• Apply liberally 15 minutes before sun exposure • Reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: ask a doctor
Package Label.Principal Display Panel
Bottle (69711 910)
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